Last year, the American Society of Clinical Oncology published recommendations to improve the evidence base for treating older adults with cancer (JCO 2015;33:3826-3833). And as part of the response to those recommendations, the FDA launched its Snapshot database (OT 2/25/2016 issue). Within that database the FDA has published information for every new molecular entity approved as of Jan. 1, 2015, on who participated in the clinical trials that supported the FDA approval of that drug, as well as any differences in the benefits and side effects based on sex, race, and age groups for that drug (http://www.fda.gov/drugtrialssnapshot).
It's a good start, but more efforts are still needed to improve the care of geriatric patients with cancer, experts have said. Arti Hurria, MD, Professor and Director of the Cancer and Aging Research Program and Co-Leader of the Cancer Control and Population Sciences Program, all at City of Hope Comprehensive Cancer Center, and several colleagues penned a letter published in the Journal of Clinical Oncology praising the Snapshot efforts, but calling for expanded steps from the FDA (2016;34:1708-1709).
The FDA should have the authority to require that studies be performed in populations most likely to have the disease for which a drug being considered for approval is intended to treat, Hurria said. "It's about the need for further research in geriatric oncology."
Hurria elaborated on how these additional actions would ultimately help improve patient care.
1 What was the key message of this letter about the Snapshot database and the FDA's efforts to improve the evidence base for treating older adults with cancer?
"We're quite happy that they have given us information for [patients] age 65 and over [via Snapshot] so that we can take a closer look at data with regard to the representation and tolerance of therapy in older adults. But there is a further opportunity to really focus on even older patients. In clinical practice we are often really struggling with patients who are 75 and older, or even 80 and over, because that's where the evidence is limited.
"So [FDA's] work needs to expand in those areas to look at those extremes of age-and break down that data for the person who is treating those patients."
2 How would having that data for older adults as part of a database like Snapshot change your experience as an oncologist treating those patients-and change the experiences of the patients themselves?
"Older adults, in general, have been underrepresented on clinical trials to date, and hence there is limited data about the risks and benefits of therapy within those older adults. Really having a chance to understand among the pivotal trials that led to FDA approval [for a drug]-how many older adults were included in those studies, as well as the average events by age strata-would at least be some level of evidence for delivering that drug in an older patient population.
"So when we're sitting in clinic where the vast majority of patients are older adults, we can at least say okay, our best quality data to date treated 'x' number of patients within your age group and these were the specific adverse events to date. I think that would be helpful. I think that would help inform that discussion with the patient.
"Also if there isn't data or very limited data it would inform that discussion with the patient, so we could be transparent that this new drug was approved, but there was limited data within your age group in particular-or there was limited data in patients that have the same co-morbid conditions that you have. Anything along those lines, I think, would be very helpful in the patient and physician interaction together."
3 In the JCO letter, you and your co-authors call for the FDA to have expanded authority to "incentivize and require research in older adults, particularly if they represent the majority of those with the disease." Could you elaborate?
"The FDA has been an advocate to do exactly what they're doing-which is trying to increase the transparency of clinical trial data with regard to patient characteristics and outcomes. But the FDA has limited authority right now in terms of being able to require that there's this data in older adults.
"Our goal is to actually have them have the authority that's needed to be able to stimulate research or require research or incentivize research in a group when there's not enough data.
"And there is a precedent (which we explain in the editorial) in pediatrics. There's been legislation to allow for additional information about drugs in children. There's something called the Best Pharmaceuticals for Children Act and the Pediatric [Research] Equity Act, and we would love to do the same for geriatrics."